MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX AQUA; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBVUNK00073

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Red Eye(s) (2038); Burning Sensation (2146); Tingling (2171); No Code Available (3191)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint sample has not returned for evaluation; the lot number is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

It was reported by an optician that a patient experienced a corneal abscess after the use of the complaint contact lenses.Additional information was received on 23oct2019 via a telephone call to the patient.It was reported that on (b)(6) 2018, the patient began to have red eye on her right eye (od) upon wearing the complaint contact lenses.The patient was unable to remove the contact lenses and a nurse removed the contact lenses for her while she was hospitalized for a different reason.The patient experienced sore eye in the presence of light and went to an ophthalmic emergency.The patient was diagnosed with corneal abscess, six lesions and was prescribed with an unspecified antibiotic drops for five days and a dressing.Six months after, the patient tried to wear the contact lenses again and experienced burning and stinging in her eyes.During a visit to the ophthalmologist on (b)(6) 2019, it was noted that the abscess was cured.Currently, the patient wore eyeglasses.Additional information has been requested but not yet received.

Manufacturer Narrative

No lot number was provided and no sample was returned for evaluation.Due to this, no lot information could be able to be performed.The trend investigation has been completed for this complaint.No any unfavorable trend identified for the entire event related to this complaint for the past months.No any significant of signal or pattern identified in the trend during this review period.The investigation could not identify a root cause to the complaint reported by the customer as no lot number was provided and no sample was returned for evaluation.Therefore, inconclusive-insufficient product or product data was concluded for this reported complaint, hence no corrective action preventive action will be initiated at this moment.The manufacturer internal reference number is: (b)(4).

• Brand Name: AIR OPTIX AQUA
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION JOHOR SDN, BHD.; #1 dpb/5 tanjung pelepas port; gelang patah; johor darul takzim johor 81560 ; MY 81560
• MDR Report Key: 9294846
• MDR Text Key: 165595450
• Report Number: 9681121-2019-00013
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBVUNK00073
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other